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Class III: unlikely to cause harmTerminated

Breckenridge Pharmaceutical Duloxetine Delayed-release Capsules Recall

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactur…

Breckenridge Pharmaceutical, Inc · Berlin, CT

Risk level
Class III
Reported by FDA
Nov 18, 2015
Recall ID
D-0181-2016
Check your lot numberHow we source this data

Summary

Breckenridge Pharmaceutical recalled Duloxetine Delayed-release Capsules starting Oct 21, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0181-2016 on Nov 18, 2015. Reason: Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

Product description

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10

Lot numbers, UPCs & expiration codes

Lot #: 142391, Exp 10/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0181-2016
Classification
Class III
Status
Terminated
Recall initiated
Oct 21, 2015
FDA report date
Nov 18, 2015
Quantity
595 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Breckenridge Pharmaceutical, Inc

Original FDA data

Every field from FDA enforcement report D-0181-2016, exactly as published.

Show all FDA fields
City
Berlin
State
CT
Status
Terminated
Country
United States
Event ID
72563
Address
15 Massirio Dr Ste 201
Code information
Lot #: 142391, Exp 10/2016
Postal code
06037-2352
Report date
Nov 18, 2015
Product type
Drugs
Recall number
D-0181-2016
Classification
Class III
Recalling firm
Breckenridge Pharmaceutical, Inc
Product quantity
595 Bottles
Termination date
Dec 24, 2015
Reason for recall
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Voluntary / mandated
Voluntary: Firm initiated
Product description
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Distribution pattern
Nationwide
Recall initiation date
Oct 21, 2015
Initial firm notification
Letter
Center classification date
Nov 10, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0181-2016, published Nov 18, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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